Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT00005061
Brief Summary:
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory solid tumors.
Detailed Description:
OBJECTIVES: I. Determine the preliminary tolerability and safety of monoclonal antibody VEGF (MOAB VEGF) in patients with relapsed or refractory progressive solid tumors. II. Determine the optimum biologically active dose of MOAB VEGF for further evaluation based on exploratory methods. III. Determine the maximum tolerated dose of MOAB VEGF in these patients. IV. Determine a safe dose of MOAB VEGF for further clinical studies. V. Determine the dose limiting toxicity and pharmacokinetics of this regimen in these patients. VI. Determine the response rate in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study. Patients receive monoclonal antibody VEGF (MOAB VEGF) IV over 1 hour on days 1, 15, 22, and 29. Patients with partial response (PR), complete response (CR), or stable disease (SD) after completion of the fourth dose may receive weekly infusions for up to 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MOAB VEGF until the maximum tolerated dose (MTD) and optimum biologically active dose (OBAD) are determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose limiting toxicity. The OBAD is defined as the dose at which vascular endothelial growth factor is optimally inhibited. Patients with PR, CR, or SD are evaluated every 6 weeks until disease progression or initiation of another treatment. Patients who discontinue treatment prematurely due to toxicity are followed weekly until resolution of any associated toxicity. Patients who discontinue treatment after the fourth dose of MOAB VEGF for any reason other than toxicity are followed every month for up to 6 months.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Study:
NCT00005061
Study Brief:
Protocol Section:
NCT00005061